Eli Lilly said Friday that the experimental anti-CGRP drug galcanezumab met the primary endpoint in three Phase III studies, demonstrating significant reductions in the number of monthly migraine headache days compared to placebo at both doses investigated. The company indicated that based on the results it plans to submit a filing to the FDA in the second half of the year, followed by submissions to other regulatory agencies around the world.

In the EVOLVE-1 and EVOLVE-2 studies, Eli Lilly evaluated the safety and efficacy of two subcutaneous doses of galcanezumab, delivered at a once-monthly dosage of 120 mg or 240 mg preceded by a 240-mg starting dose, versus placebo in patients with episodic migraine, defined as four to 14 migraine headache days per month. The primary endpoint of the study was the mean change versus baseline in monthly migraine headache days over a six-month period compared to placebo.

Meanwhile, the REGAIN study examined the same treatment regimen in patients who experienced at least 15 migraine days per month. The main study goal was the mean change from baseline in monthly migraine headache days versus placebo over a three-month period, with patients further evaluated in a nine-month open-label extension phase.

Results from EVOLVE-1 trial illustrated that the low and high doses of galcanezumab reduced the number of migraine days per month by 4.7 days and 4.6 days, respectively, compared to 2.8 days for placebo. Similarly, in the EVOLVE-2 study, galcanezumab administered at low and high doses cut the number of monthly migraine days by 4.3 days and 4.2 days, respectively, versus 2.3 days for placebo.

Moreover, in the REGAIN study, galcanezumab administered at low and high doses decreased the number of monthly migraine days by 4.8 days and 4.6 days, respectively, compared to 2.7 days in the placebo group. The drugmaker noted that in all three trials, patients treated with the active therapy experienced significant improvements in several pre-specified secondary endpoints, including response rates and measures of daily activities.

Eli Lilly, which regained development rights to galcanezumab in 2014, is also examining the drug as a treatment for cluster headache, with late-stage study data anticipated next year. The therapy, formerly known as LY2951742, was previously granted fast track designation by the FDA for this indication. Analysts have estimated that the drug could generate $480 million in annual revenue by 2021.